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Completed

NCT Number: NCT07452835

Transcranial Direct Current Stimulation (tDCS) in Different Psychiatric Disorders

The goal of this clinical trial is to evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in reducing core symptoms of different psychiatric disorders using validated clinical scales.

* To assess response and remission rates. * To evaluate the durability of treatment effects over follow-up. * To examine effects on cognition, daily functioning, and quality of life. * To monitor tolerability and adverse events.

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Key information

Conditions

Major Depressive Disorder (MDD) Anxiety Disorders Depressive Disorder Depressive Disorder, Major Dyssomnias Generalized Anxiety Disorder Insomnia Mental Disorders Mood Disorders Nervous System Diseases Obsessive-Compulsive Disorder SCHIZOPHRENIA 1 (Disorder) Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Cairo, Menofia, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 16 and 65 years
  • Fulfillment of DSM-5 diagnostic criteria for one of the target disorders
  • Stable pharmacological treatment for at least four weeks prior to enrollment (if applicable)
  • Ability to provide informed consent

Exclusion criteria

  • History of epilepsy or seizures
  • Presence of intracranial metallic implants or implanted electronic devices
  • Severe neurological disorders (e.g., brain tumors)
  • Pregnancy
  • Active substance use disorder
  • Severe cognitive impairment or comorbid psychiatric disorders interfering with assessment

Treatment and study plan

tDCS Parameters

Device

Preparation:

  • Clean scalp with alcohol to reduce impedance.
  • Apply conductive gel and position electrodes using the 10-20 EEG system.
  • Use rubber electrodes (5×7 cm) for anodal/cathodal placement.

Stimulation:

Ramp-up current over 30 sec to avoid discomfort. Monitor for adverse effects (tingling, itching, headache ).

Post-Stimulation Assessment:

  • Evaluate symptom changes using standardized scales (e.g., HAM-D for depression, Y-BOCS for OCD).
  • Repeat sessions 3-5 times per week.. Safety and Monitoring

Adverse Effects:

Mild skin irritation, headache (rarely seizures-screen high-risk patients(.

Contraindications:

Metallic implants, scalp lesions, epilepsy history. Conclusion tDCS is a promising neuromodulatory tool for psychiatric disorders, with varying protocols based on disorder-specific neural targets.

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale

    Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.

    Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale. The total scores on this scale range from a minimum of 0 to a maximum of 60, with higher scores indicating a greater severity of depressive symptoms (a worse outcome)

  2. Positive and Negative Syndrome Scale

    Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.

    Symptom severity was evaluated using the Positive and Negative Syndrome Scale. Total scores on this scale range from a minimum of 30 to a maximum of 210, with higher scores indicating a greater severity of symptoms (a worse outcome).

Secondary outcomes

  1. Yale-Brown Obsessive Compulsive Scale

    Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.

    The severity of obsessive-compulsive symptoms was measured using the Yale-Brown Obsessive Compulsive Scale. Total scores on this scale range from a minimum of 0 to a maximum of 40, with higher scores indicating more severe symptoms (a worse outcome).

  2. Generalized Anxiety Disorder-7

    Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.

    Anxiety severity was measured using the Generalized Anxiety Disorder-7 scale. Total scores on this scale range from a minimum of 0 to a maximum of 21, with higher scores indicating more severe anxiety symptoms (a worse outcome).

  3. Insomnia Severity Index - 7 items

    Time frame: The assessment period for each participant was 24 weeks from the start of their participation in the study.

    The severity of insomnia was assessed using the Insomnia Severity Index. Total scores on this scale range from a minimum of 0 to a maximum of 28, with higher scores indicating more severe insomnia symptoms (a worse outcome).

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Acronym: Transcranial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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